Identifiers
- 510(k) Number
- K183438 FDA 510(k)
- FDA Product Code
- DWP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4475 FDA 510(k)
- Regulation Number
- 870.4475 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Geomed Vascular Dilators are a type of dilator, vessel, surgical device. They are used in cardiovascular applications. The device is classified as a class 2 device.
The Geomed Vascular Dilators are supplied with a product code of DWP and a regulation number of 870.4475. They have been cleared by the FDA with a 510K clearance. The device is manufactured by Geomed Medizin-Technik GmbH & Co.
Frequently asked questions
What are the Geomed Vascular Dilators used for?
The Geomed Vascular Dilators are used in cardiovascular applications, specifically as a type of dilator, vessel, surgical device.
What is the regulatory status of the Geomed Vascular Dilators?
The Geomed Vascular Dilators have been cleared by the FDA with a 510K clearance, classified as a class 2 device.
What product code and regulation number do the Geomed Vascular Dilators have?
The Geomed Vascular Dilators have a product code of DWP and a regulation number of 870.4475.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Startseite - GEOMED Kreisklinik, GEOMED-KREISKLINIK GmbH – Gemeinde Sulzheim, Geomed-Kreisklinik in Gerolzhofen – Klinikradar
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183438 | Class II | Active |
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Manufacturer
- Manufacturer
- Geomed Medizin-Technik GmbH & Co.
Sources (1)
- FDA 510(k) K183438 24 fields · synced Oct 6, 2026